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A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

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ClinicalTrials.gov Identifier: NCT02263456
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Brief Summary:

The purpose of this study is:

  • to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
  • to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.
  • to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.

Condition or disease Intervention/treatment Phase
Haemophilia B Biological: Replenine®-VF (High Purity Factor IX) Phase 3

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.
Study Start Date : July 1997
Actual Primary Completion Date : September 2001


Arm Intervention/treatment
Active Comparator: Current Factor IX Biological: Replenine®-VF (High Purity Factor IX)
Experimental: Replenine®-VF Biological: Replenine®-VF (High Purity Factor IX)



Primary Outcome Measures :
  1. Area under the concentration/time curve (AUC) for plasma Factor IX [ Time Frame: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 12 years or over
  • At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263456


Locations
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United Kingdom
The Royal Free Hospital, Pond Street
Hampstead, London, United Kingdom
The North Hampshire Hospital, Aldermaston Road
Basingstoke, United Kingdom
Addenbrooke's Hospital, Hills Road
Cambridge, United Kingdom
University Hospital of Wales, Health Park
Cardiff, United Kingdom
Kingston General Hospital, Beverly Road
Hull, United Kingdom
Leicester Royal Infirmary, Infirmary Square
Leicester, United Kingdom
Lincoln County Hospital, Greetwell Road
Lincoln, United Kingdom
Sponsors and Collaborators
Bio Products Laboratory

Additional Information:
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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02263456     History of Changes
Other Study ID Numbers: RP9VFPK
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked